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NCT02048241 · ClinicalTrials.gov registry record · Phase 4
Intuniv vs Placebo in the Treatment of Childhood Intermittent Explosive Disorder
A Phase 4 study, sponsored by New York State Psychiatric Institute.
- Completed
- Registry status
- Phase 4
- Development phase
- 11
- Enrollment target
NCT02048241 is a Phase 4 study that has completed, run by New York State Psychiatric Institute. The registered enrollment target is 11 participants.
The verdict
NCT02048241, a Phase 4 study, has completed, sponsored by New York State Psychiatric Institute.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 11 participants
- Enrollment target
Study Summary
Children with explosive aggression are often rejected by their peers, placed in special classroom, and contribute to family discord. When psychotherapy and family therapy is unsuccessful, medications are often used. Current medications are stimulants (e.g. methylphenidate, dextroamphetamine), anticonvulsants (e.g. Divalproex) and antipsychotics (olanzapine, risperidone). At this time, the available medications are of limited usefulness, either because they do not always work or because they have side effects such as weight gain or insomnia. There is a clear need for new medications to treat explosive aggression when psychotherapy is unsuccessful. The hypothesis of this study is the medication Intuniv when combined with psychotherapy will be more helpful to children with explosive aggression than placebo combined with psychotherapy. Intuniv is a long acting form of guanfacine, a medication approved by the FDA for treatment of Attention Deficit Hyperactivity Disorder. Intuniv is not a stimulant, nor is it an anticonvulsant, nor is it an antipsychotic. The children in this study will be between the ages of 6 and 12 and meet Diagnostic and Statistical Manual of Psychiatry Fourth Edition, Text Revision (DSM-IV-TR) criteria for Intermittent Explosive Disorder.
Interventions
- OTHER Placebo
- BEHAVIORAL Parent Management Training
- DRUG Intuniv
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2011-07 |
| Est. Completion | 2014-12 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02048241
The ClinicalTrials.gov registry entry for NCT02048241 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is New York State Psychiatric Institute, which has 364 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02048241 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02048241 about?
NCT02048241 is a clinical study titled "Intuniv vs Placebo in the Treatment of Childhood Intermittent Explosive Disorder". Children with explosive aggression are often rejected by their peers, placed in special classroom, and contribute to family discord. When psychotherapy and family therapy is unsuccessful, medications are often used. Current medications are stimulants (e.g. methylphenidate, dextroamphetamine), antico...
What is the current status of trial NCT02048241?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 11 participants. The study started on 2011-07. Estimated completion is 2014-12.
What interventions are being tested in trial NCT02048241?
The interventions under investigation include: Placebo (OTHER), Parent Management Training (BEHAVIORAL), Intuniv (DRUG).
Who is sponsoring clinical trial NCT02048241?
This trial is sponsored by New York State Psychiatric Institute, which has 364 total clinical trials registered on ClinicalTrials.gov.
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